If you’re interested in new tech and innovation – including outside of the biopharma space – and enjoy warm weather and coastlines, you won’t help but envy Ravi Kiron. Merck KGaA has given him the job of all jobs. Kiron has became the head of biopharma external innovation at Merck’s EMD Serono, Inc., and tasked with establishing its Silicon Valley Innovation Hub. Try not to be too jealous of Kiron as you’re reading. More jobs like his may be on the way.
FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
I recently talked to a good friend who sold his company, a midsize service provider, to a much larger global end-to-end CDMO. His experience was not atypical of the trend that has been going on for the better part of the past decade. Namely, that the industry is consolidating, moving to a more strategic outsourcing relationship where end-to-end service offerings seem to dominate over the traditional focused-service model.
Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.
Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises
Transferring production – and the technologies that undergird it – can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.
Important things come in packages of all sizes, especially in the world of temperature-controlled, pharmaceutical transport, where it is not uncommon for even the smallest shipment to have a far-reaching impact on researchers, manufacturers, healthcare providers and patients.
The multimodal ligand of Capto™ MMC generally requires elution conditions that diff er from those used with traditional ion exchangers. This application note describes how Design of Experiments (DoE) can be used to optimize elution conditions and thus recovery of a target protein
Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium is designed for the polishing steps of monoclonal antibodies (MAbs) and a wide range of other biomolecules.
This application note describes the physical characteristics of the XDR-2000 bioreactor system suitable for use in mammalian cell culture applications.
An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease.
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Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error.
Formulation techniques and technologies can easily become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.
By thinking outside of the box, CDMOs can create a flexible and scalable business model that offers a level of assurance in the face of forecast variability.